The Evaluation of the Safety and the Efficacy of Transanal Total Mesorectal Excision

Rectal Cancer Clinical Trial

Official title:

A Pilot Study for the Evaluation of the Safety and the Efficacy of Transanal Total Mesorectal Excision

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01938027
• Other study ID #: NCC-TAME
• Secondary ID: NCC-1210170
• Status: Completed
• Phase: N/A
• First received: September 4, 2013
• Last updated: March 25, 2015
• Start date: September 2013
• Est. completion date: August 2014

Study information

• Verified date: March 2015
• Source: National Cancer Center, Korea
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: National Cancer CenterKorea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is evaluation of the safety and the efficacy of transanal total mesorectal excision.

Description:

Subjects will have their rectal cancer removed using a technique combining surgery through the anus and standard laparoscopy. Transanal visualization will be using endoscopy. At the end of the procedure, the rectum will be removed though the anus or ileostomy formation site, the bowel will be re-connected to the anus, and a temporary diverting stoma will be created, which is standard of care following surgery for this type of cancer.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• age: 20-80 years

• biopsy-proven adenocarcinoma of the rectum

• clinical staging, (T1 or T2 or T3) with N0M0

• Rectal cancer located 4-12 cm from the anal verge

• ECOG performance status 2 or less

Exclusion Criteria:

• Synchronous colon cancer or other malignancy

• Obstructing rectal cancer

• Pregnant or breast-feeding

• Receiving any other study agents

• Fecal incontinence

• History of prior colorectal cancer or inflammatory bowel disease

• BMI > 30

• T3 rectal cancer not treated preoperatively with full-course chemoradiation

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rectal Cancer

Intervention

Procedure:
• Transanal total mesorectal excision
Laparoscopy-assisted transanal total mesorectal excision

Locations

Country	Name	City	State
Korea, Republic of	Jae Hwan Oh	Goyang-si	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Center, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Oncologic outcome(2-year local recurrence free survival, 5-year survival)		1-5 years	Yes
Primary	Total Mesorectal Excision(TME) quality	The quality of the mesorectum was determined using pathology reports and scored using three grades: Complete: intact mesorectum with only minor irregularities of a smooth mesorectal surface. No defect is deeper than 5 mm, and there is no coning toward the distal margin of the specimen. There is a smooth circumferential resection margin on slicing.; Nearly complete: moderate bulk to the mesorectum, but irregularity of the mesorectal surface. Moderate coning of the specimen is allowed. At no site is the muscularis propria visible, with the exception of the insertion of the levator muscles.; Incomplete: little bulk to mesorectum with defects down onto muscularis propria and/or very irregular circumferential resection margin.	1-5 years	No
Secondary	30-day postoperative complications, No. of harvested LN		1-5 years	Yes